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ANAVEX3-71 for Schizophrenia (SZ-001 Trial)
Phase 2
Recruiting
Research Sponsored by Anavex Life Sciences Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a primary diagnosis of schizophrenia for ≥ 1 year
Stable schizophrenia psychiatric symptoms for at least 6 weeks prior to screening
Must not have
Any primary the DSM-5-TR disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening)
Has psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [part a and part b screening to safety follow up visit] up to 78 days (part a) and up to 114 days (part b)
Summary
This trial will test a new drug called ANAVEX3-71 to see if it is safe and effective in treating patients with Schizophrenia. The study will also look at how the drug is
Who is the study for?
Adults aged 18-50 with stable schizophrenia, on consistent antipsychotic medication for at least 6 weeks, and a BMI between 18.5 to 40 kg/m2 can join this trial. They must have a specific cognition score, not be drug or alcohol users, and agree to stay inpatient as required. Pregnant individuals or those with recent investigational drug use are excluded.
What is being tested?
The study is testing ANAVEX3-71 oral capsules against placebo to assess their safety and effectiveness in treating schizophrenia symptoms. It also looks into how the body processes the drug and its effects on brain function.
What are the potential side effects?
While the side effects of ANAVEX3-71 aren't detailed here, common side effects for similar treatments may include dizziness, gastrointestinal discomfort, changes in weight or appetite, restlessness, and potential metabolic changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia for at least 1 year.
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My schizophrenia symptoms have been stable for at least 6 weeks.
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I am between 18 and 50 years old.
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My mental health score has not worsened by more than 20% and is 80 or less.
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My schizophrenia symptoms are mild based on specific test scores.
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My BMI is between 18.5 and 40, and my weight is over 110 lbs if male, or over 88 lbs if female.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not been diagnosed with a mental health disorder other than schizophrenia in the past year.
Select...
I have been in a psychiatric hospital for more than 30 days in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ [part a and part b screening to safety follow up visit] up to 78 days (part a) and up to 114 days (part b)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[part a and part b screening to safety follow up visit] up to 78 days (part a) and up to 114 days (part b)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
12-lead ECG (P wave)
12-lead ECG (PR interval)
12-lead ECG (PR segment)
+36 moreSecondary study objectives
Blood measurements of chitinase-3-like protein 1 (YKL-40)
Blood measurements of circulating amino acid metabolites
Blood measurements of glial fibrillary acidic protein (GFAP)
+5 moreTrial Design
5Treatment groups
Active Control
Placebo Group
Group I: ANAVEX3-71 30 mg TID (Part A)Active Control1 Intervention
The first active treatment arm of the study during Part A (multiple ascending doses).
Group II: ANAVEX3-71 60 mg TID (Part A)Active Control1 Intervention
The second active treatment arm of the study during Part A (multiple ascending doses).
Group III: ANAVEX3-71 TBD mg TID (Part B)Active Control1 Intervention
The active arm of Part B of the study. The dose will be determined based on data obtained in Part A.
Group IV: ANAVEXX3-71 Placebo TID (Part A)Placebo Group1 Intervention
The placebo arm of Part A (multiple ascending doses).
Group V: ANAVEX3-71 Placebo TID (Part B)Placebo Group1 Intervention
The placebo arm of Part B of the study.
Find a Location
Who is running the clinical trial?
Hassman Research InstituteUNKNOWN
Cognitive Research CorporationIndustry Sponsor
24 Previous Clinical Trials
2,348 Total Patients Enrolled
4 Trials studying Schizophrenia
981 Patients Enrolled for Schizophrenia
COGNISIONUNKNOWN
2 Previous Clinical Trials
194 Total Patients Enrolled
1 Trials studying Schizophrenia
161 Patients Enrolled for Schizophrenia
Anavex Life Sciences Corp.Lead Sponsor
12 Previous Clinical Trials
1,512 Total Patients Enrolled
1 Trials studying Schizophrenia
161 Patients Enrolled for Schizophrenia